Shire US announced positive top-line results from a Phase 2 study of Vyvanse (lisdexamfetamine dimesylate) Capsules in adults with binge eating disorder.
This study was a multi-center, randomized, double-blind, parallel-group, placebo-controlled, forced-dose titration study to assess the efficacy, safety and tolerability of Vyvanse in 270 adults aged 18–55 who met the criteria for a diagnosis of binge eating disorder. The primary objective of the study was to evaluate the efficacy of 30, 50 or 70 mg of Vyvanse compared to placebo in the treatment of binge eating disorder at Week 11 as measured by the number of binge days per week as assessed by clinical interview based on patient diary. A binge day was defined as a day during which at least one binge episode occurred.
Vyvanse 50mg and 70mg were statistically superior to placebo on the primary end point. Vyvanse 30mg was not statistically superior to placebo on the primary end point, clarifying the dose range for future trials in this patient population.
Vyvanse, a schedule II narcotic, is a stimulant indicated for the treatment of ADHD in children ages 6–17 and adults and for the maintenance of ADHD in adults ages 18–55.
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